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Bioequivalence and Pharmacokinetics Comparison of Two Formulations of Extended-Release Pentoxifylline Tablets in Healthy Subjects after Fasting and Fed Conditions
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The pharmacokinetics and bioequivalence of a newly developed extended-released (ER) tablet containing 400 mg pentoxifylline as a test product was compared with the reference brand product Trental® 400 mg ER tablet produced by Sanofi-Aventis. Two separate studies were conducted simultaneously. The first study was conducted under fasting condition, whereas, the second study was conducted under fed condition; using the same batches of the test and reference products in both studies. In each study, both products were administered to 32 healthy male adult volunteers applying a single-dose, two-treatment, two-period, two-sequence, randomized crossover design with one-week washout period between dosing. Twenty two blood samples were withdrawn from each volunteer over 24 hours period.  Pentoxifylline concentrations were determined in plasma by a validated HPLC method according to FDA Bioanalytical Method Validation Guidance using UV detection and chloramphenicol as internal standard. The lower limit of quantitation of the drug in plasma was 5 ng/ml and the upper limit of quantitation was 500 ng/ml. From the plasma concentration-time data of each individual, the pharmacokinetic parameters; Cmax,  AUC0-t, AUC0-Â¥, Cmax/AUC0-Â¥, Tmax, lZ & T0.5; were calculated applying non-compartmental analysis. Data of the test and reference products were statistically analyzed to test for bioequivalence of the two products, using criteria of FDA and EMEA Guidance.  The pharmacokinetic parameters mentioned above were statistically analyzed by descriptive statistics, ANOVA test and 90% Confidence Interval (CI). ANOVA test involved the calculation of the effects of: treatment, period, sequence and subjects nested in sequence. According to the above guidance, the primary pharmacokinetic parameters used for bioequivalence testing, namely Cmax, AUC0-t and AUC0-Â¥ were also statistically analyzed by ANOVA & CI tests using the corresponding Ln-transformed values. The mean values  Cmax,  AUC0-t , AUC0-Â¥ , Cmax/AUC0-Â¥ , Tmax, lZ & T0.5 for the test formula obtained from the fasting study  were; 144.4 ng/ml,  845.4 ng.hr/ml, 868.4 ng.hr/ml, 0.186 hr-1, 3.29 hr, 0.561 hr-1 and 1.65 hr, respectively; and the mean values of these parameters for the reference formula were; 150.0 ng/ml,  871.1 ng.hr/ml, 893.7 ng.hr/ml, 0.177 hr-1, 3.70 hr, 0.558 hr-1 and 1.59 hr,  respectively.  The mean values of the above mentioned parameters for the test formula obtained from the fed study were; 157.8 ng/ml, 826.5 ng.hr/ml, 853.8 ng.hr/ml, 0.198 hr-1, 5.4 hr, 0.458 hr-1 and 2.06 hr, respectively; and the mean values of these parameters for the reference formula were; 162.1 ng/ml, 869.7 ng.hr/ml, 894.8 ng.hr/ml, 0.196 hr-1, 4.1 hr, 0.525 hr-1 and 1.80 hr, respectively.  Based on criteria of FDA and   EMEA Guidance on Bioavailability and Bioequivalence, the results of the fasting and fed studies demonstrated bioequivalence of the two products under either condition. Accordingly, it is concluded that the newly developed ER tablet containing 400 mg pentoxifylline is bioequivalent to Trental® 400 mg ER tablet produced by Sanofi-Aventis.

Keywords: Pentoxifylline, Pharmacokinetics, Bioequivalence.

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Publication Date
Tue Jan 01 2019
Journal Name
International Journal Of Agricultural And Statistical Sciences,
The comparison of several methods for calculating the degree of heritability and calculating the number of genes II. Yield components
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Publication Date
Tue Apr 01 2014
Journal Name
Structural Science, Crystal Engineering And Materials
Comparison of the structural motifs and packing arrangements of six novel derivatives and one polymorph of 2-(1-phenyl-1H-1,2,3-triazol-4-yl)pyridine
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The crystal structures of a new polymorph and seven new derivatives of 2-(1-phenyl-1H-1,2,3-triazol-4-yl)pyridine have been characterized and examined along with three structures from the literature to identify trends in their intermolecular contact patterns and packing arrangements in order to develop an insight into the crystallization behaviour of this class of compound. Seven unique C-H...X contacts were identified in the structures and three of these are present in four or more structures, indicating that these are reliable supramolecular synthons. Analysis of the packing arrangements of the molecules using XPac identified two closely related supramolecular constructs that are present in eight of the 11 structures; in all cases, the st

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Publication Date
Sun Dec 31 2017
Journal Name
College Of Islamic Sciences
Mask technique in the poem "Christ after the crucifixion" for Bder Shaker Al_Sayab
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Research summary

Perhaps the methods of mask that Arab poets resorted to in our time are due to the conditions of oppression and political and social repression that the Arab poet suffered from; So he strived to circumvent it, and it became a justification for hiding behind it. The research is available on a number of topics that lead to the definition of the mask technique and the beginning of its prevalence in Arabic literature after the Second World War, especially in recent decades by benefiting from historical stories, fairy tales and legends of all kinds. As well as defining the mask idiomatically and linguistically, and the beginning of its use in ancient religious rituals, and the special place it had in Greek plays. Poets

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Publication Date
Wed Jan 02 2019
Journal Name
Journal Of The College Of Languages
The Outcomes of War: A Study of the Character After the Crisis of War
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World War II has brought suffering for all people; it has led people to have a nostalgic feeling. The war has many faces all of them are ugly, like death, separation, loneliness, violence, crime, betrayal, and disconnection and many other meanings. Michael Ondaatje in his novel The English Patient (1992) portrays a picture of the effect of World War II on four different characters; Hana a Canadian nurse, The English patient who is Hungarian, Caravaggio a Canadian-Italitan thief, and Kip an Indian sapper. They live together in one house, share their secrets and memories about World War II. Ondaatje brings them together to reveal their secrets and to heal their wounds of the war experience.

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Publication Date
Wed Jan 02 2019
Journal Name
Journal Of The College Of Languages (jcl)
The Outcomes of War: A Study of the Character After the Crisis of War
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World War II has brought suffering for all people; it has led people to have a nostalgic feeling. The war has many faces all of them are ugly, like death, separation, loneliness, violence, crime, betrayal, and disconnection and many other meanings. Michael Ondaatje in his novel The English Patient (1992) portrays a picture of the effect of World War II on four different characters; Hana a Canadian nurse, The English patient who is Hungarian, Caravaggio a Canadian-Italitan thief, and Kip an Indian sapper. They live together in one house, share their secrets and memories about World War II. Ondaatje brings them together to reveal their secrets and to heal their wounds of the war experience.

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Publication Date
Sat Sep 12 2020
Journal Name
Al-kindy College Medical Journal
Spectrum of central nervous system infections in neurosciences hospital in two years : a retrospective study
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Background :Infectious disorders in general have high morbidity and mortality.. CNS infections include many disorders like bacterial meningitis, tuberculous and other subacute and chronic meningitis, viral meningitis, cerebral abscess, spinal cord infections, and others.
Objective: To assess our locality about prevalence of CNS infections , to have more awareness regarding CNS infections, and to try to find the proper way to reduce their prevalence and to treat them in appropriate way.
Method :We revised the records of all the cases of CNS infections excluding cases of spinal cord infections who were admitted in the wards of neuroscience hospital over the previous two years ( from July/2010 to June 2012 ),those were 132 cases.Seaso

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Publication Date
Thu Aug 01 2019
Journal Name
Journal Of Economics And Administrative Sciences
Some Estimation methods for the two models SPSEM and SPSAR for spatially dependent data
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ABSTRUCT

In This Paper, some semi- parametric spatial models were estimated, these models are, the semi – parametric spatial error model (SPSEM), which suffer from the problem of spatial errors dependence, and the semi – parametric spatial auto regressive model (SPSAR). Where the method of maximum likelihood was used in estimating the parameter of spatial error          ( λ ) in the model (SPSEM), estimated  the parameter of spatial dependence ( ρ ) in the model ( SPSAR ), and using the non-parametric method in estimating the smoothing function m(x) for these two models, these non-parametric methods are; the local linear estimator (LLE) which require finding the smoo

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Publication Date
Tue Apr 02 2024
Journal Name
Engineering, Technology & Applied Science Research
Two Proposed Models for Face Recognition: Achieving High Accuracy and Speed with Artificial Intelligence
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In light of the development in computer science and modern technologies, the impersonation crime rate has increased. Consequently, face recognition technology and biometric systems have been employed for security purposes in a variety of applications including human-computer interaction, surveillance systems, etc. Building an advanced sophisticated model to tackle impersonation-related crimes is essential. This study proposes classification Machine Learning (ML) and Deep Learning (DL) models, utilizing Viola-Jones, Linear Discriminant Analysis (LDA), Mutual Information (MI), and Analysis of Variance (ANOVA) techniques. The two proposed facial classification systems are J48 with LDA feature extraction method as input, and a one-dimen

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Publication Date
Mon Jun 05 2023
Journal Name
Al-khwarizmi Engineering Journal
Determination of the Optimum Conditions for Removal of Congo Red Dye by Peroxidase Enzyme Plant
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The pollution producing from textile industries effluents is growing since the years, due to at discharged lots of it in water without treatment. The resulting effluent is colourful, highly toxic, and poses a significant environmental hazard. This problem can be solved by using enzymic biological treatment, where the Congo red dye was used with concentrations (100,200,300,500) mg /L, pH values (3,4,5,6,7,8), and variable temperatures (25,35,45)°C, the best removal of Congo red (CR) dye  under optimum conditions for degradation was at  concentration of 100 mg/L, at (pH 6, 25 °C) with efficiency of 99.85 % using the peroxidase enzyme extracted from red radish plant, while the removal percentage decreased when increase dye concentration

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Publication Date
Mon Aug 19 2024
Journal Name
Scientific Reports
An in-vitro evaluation of residual dentin retained after using novel enzymatic-based chemomechanical caries removal agents
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To assess the biochemical, mechanical and structural characteristics of retained dentin after applying three novel bromelain‑contained chemomechanical caries removal (CMCR) formulations in comparison to the conventional excavation methods (hand and rotary) and a commercial papain‑contained gel (Brix 3000). Seventy‑two extracted permanent molars with natural occlusal carious lesions (score > 4 following the International Caries Detection and Assessment System (ICDAS‑II)) were randomly allocated into six groups (n = 12) according to the excavation methods: hand excavation, rotary excavation, Brix 3000, bromelain‑contained gel (F1), bromelain‑chloramine‑T (F2), and bromelain chlorhexidine gel (F3). The superficial and deepe

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